JP2024503382A - Electrical stimulation cuff devices and systems with directional electrode configurations - Google Patents

Abstract

The electrical stimulation lead includes a cuff body having an outer surface, an inner surface, and a periphery, and at least 16 elongated electrodes disposed on the inner surface of the cuff body spaced apart from each other in a circumferential arrangement around the periphery of the cuff body. a cuff having at least one set of longitudinal electrodes, each set comprising a longitudinal electrode, and a longitudinal slit extending through the cuff body and further extending along the length of the cuff body. The electrical stimulation lead also includes a lead body coupled to the cuff and a conductor extending through the lead body and the cuff and electrically coupled to the electrode. [Selection diagram] Figure 3

Description

[Cross reference to related applications]
This application is filed under ``35 U.S.C. It claims profits in

The present disclosure relates to the field of implantable electrical stimulation systems and methods of making and using the systems. The present disclosure also relates to implantable electrical stimulation cuff devices and methods of making and using the same.

Implantable electrical stimulation systems have demonstrated therapeutic efficacy in a variety of diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes. Peripheral nerve stimulation has been used to treat chronic pain syndromes and incontinence, along with several other under investigation applications. Functional electrical stimulation systems have been applied to restore some function to paralyzed limbs in patients with spinal cord injuries. Brain stimulation, such as deep brain stimulation, can be used to treat a variety of diseases or disorders.

Stimulators have been developed to provide therapy for a variety of treatments. The stimulator can include a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead. The stimulator electrode is in contact with or near the nerve, muscle, or other tissue to be stimulated. A pulse generator within the control module generates electrical pulses that are delivered to body tissue by the electrodes.

US Patent No. 6,181,969 US Patent No. 6,516,227 US Patent No. 6,609,029 US Patent No. 6,609,032 US Patent No. 6,741,892 U.S. Patent No. 7,203,548 U.S. Patent No. 7,244,150 US Patent No. 7,450,997 US Patent No. 7,596,414 US Patent No. 7,610,103 US Patent No. 7,672,734 US Patent No. 7,761,165 US Patent No. 7,783,359 US Patent No. 7,792,590 US Patent No. 7,809,446 US Patent No. 7,949,395 US Patent No. 7,974,706 US Patent No. 6,175,710 US Patent No. 6,224,450 US Patent No. 6,271,094 US Patent No. 6,295,944 US Patent No. 6,364,278 US Patent No. 6,391,985 US Patent Application Publication No. 2007/0150036 US Patent Application Publication No. 2009/0187222 US Patent Application Publication No. 2009/0276021 US Patent Application Publication No. 2010/0076535 US Patent Application Publication No. 2010/0268298 US Patent Application Publication No. 2011/0004267 US Patent Application Publication No. 2011/0078900 US Patent Application Publication No. 2011/0130817 US Patent Application Publication No. 2011/0130818 US Patent Application Publication No. 2011/0238129 US Patent Application Publication No. 2011/0313500 US Patent Application Publication No. 2012/0016378 US Patent Application Publication No. 2012/0046710 US Patent Application Publication No. 2012/0071949 US Patent Application Publication No. 2012/0165911 US Patent Application Publication No. 2012/0197375 US Patent Application Publication No. 2012/0203316 US Patent Application Publication No. 2012/0203320 US Patent Application Publication No. 2012/0203321 US Patent Application Publication No. 2012/0316615 US Patent Application Publication No. 2013/0105071 U.S. Patent Application No. 12/177,823 U.S. Patent Application No. 13/750,725 US Patent No. 7,596,414 US Patent No. 7,974,706 US Patent No. 8,423,157 US Patent No. 10,485,969 US Patent No. 10,493,269 US Patent No. 10,709,888 US Patent No. 10,814,127 US Patent Application Publication No. 2017/0333692 US Patent Application Publication No. 2018/0154156 US Patent No. 8,224,450 US Patent No. 8,423,154 US Patent No. 8,606,362 US Patent No. 8,620,436 US Patent No. 9,308,383 US Patent No. 9,568,053 US Patent No. 10,350,413 US Patent No. 10,537,741 US Patent Application Publication No. 2018/0071520 US Patent Application Publication No. 2019/0083796

One aspect includes a cuff body having an outer surface, an inner surface, and a periphery, and a longitudinal electrode disposed on the inner surface of the cuff body, each longitudinal electrode having a length/width aspect ratio of at least 20. , a longitudinal electrode extending through the cuff body with the longitudinal electrodes being divided into at least one set, each set comprising at least 16 longitudinal electrodes spaced apart from each other in a circumferential arrangement around the periphery of the cuff body. and further having a longitudinal slit extending along the entire length of the cuff body and operable to receive a portion of the target nerve from an area outside the cuff into the cuff body. The electrical stimulation lead also includes a lead body coupled to the cuff and a conductor extending through the lead body and the cuff, the conductor being electrically coupled to the longitudinal electrode.

In at least some embodiments, each of the elongated electrodes has an aspect ratio of at least 50. In at least some aspects, each of the elongated electrodes has a width of no greater than 100 μm. In at least some aspects, each of the elongated electrodes has a length of at least 1 mm. In at least some aspects, each of the at least one set includes at least 32 longitudinal electrodes spaced apart from each other in a circumferential arrangement about the periphery of the cuff body.

In at least some aspects, the cuff further includes at least one radial electrode extending around at least 75% of the circumference of the cuff body. In at least some aspects, the cuff further includes at least one set of radial electrodes, each set of radial electrodes including at least one of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body. Including two.

Another aspect is a cuff body having an outer surface, an inner surface, and a periphery, and a longitudinal electrode disposed on the inner surface of the cuff body, each of the longitudinal electrodes having a width of no more than 100 μm; said longitudinal electrodes being divided into at least one set, each set comprising at least 16 longitudinal electrodes spaced apart from each other in a circumferential arrangement around the periphery of the cuff body; an electrical stimulation lead including a cuff having a longitudinal slit further extending along the length of the cuff and operable to receive a portion of the target nerve from an area outside the cuff into the body of the cuff. The electrical stimulation lead also includes a lead body coupled to the cuff and a conductor extending through the lead body and the cuff, the conductor being electrically coupled to the longitudinal electrode.

In at least some embodiments, each of the elongated electrodes has an aspect ratio of at least 50. In at least some aspects, each of the elongated electrodes has a length of at least 1 mm. In at least some aspects, each of the at least one set includes at least 32 longitudinal electrodes spaced apart from each other in a circumferential arrangement about the periphery of the cuff body.

In at least some aspects, the cuff further includes at least one radial electrode extending around at least 75% of the circumference of the cuff body. In at least some aspects, the cuff further includes at least one set of radial electrodes, each set of radial electrodes including at least one of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body. Including two.

Yet another aspect includes a cuff body having an outer surface, an inner surface, and a periphery, and a longitudinal electrode disposed on the inner surface of the cuff body, the elongated electrodes having at least 16 elongated electrodes spaced apart from each other in a circumferential arrangement about the periphery of the cuff body. At least 75% of the circumference of the cuff body is covered with at least 75% of the circumference of the cuff body, either alone or in combination with 2 or more radial electrodes ( (e.g., when there are two or more radial electrodes) one or more radial electrodes extending through the cuff body and further extending along the entire length of the cuff body from an area outside the cuff body; and a longitudinal slit operable to receive a portion of the target nerve into the electrical stimulation lead. The electrical stimulation lead also includes a lead body coupled to the cuff and a conductor extending through the lead body and the cuff, the conductor being electrically coupled to the longitudinal electrode and the radial electrode.

In at least some embodiments, each of the elongated electrodes has an aspect ratio of at least 50. In at least some aspects, each of the elongated electrodes has a width of no greater than 100 μm. In at least some aspects, each of the elongated electrodes has a length of at least 1 mm. In at least some aspects, each of the at least one set includes at least 32 longitudinal electrodes spaced apart from each other in a circumferential arrangement about the periphery of the cuff body.

In at least some aspects, the cuff further includes at least two sets of radial electrodes, each set of radial electrodes including at least one of the radial electrodes extending around at least 75% of the circumference of the cuff body. . In at least some aspects, at least one of the sets of radial electrodes includes at least two of the radial electrodes that extend in combination around at least 75% of the circumference of the cuff body. In at least some aspects, the cuff further includes a cushioning layer disposed over the interior surface of the cuff body.

Non-limiting and non-exhaustive embodiments of the invention will be described with reference to the following drawings. In the drawings, like reference numbers refer to like parts throughout the various figures, unless otherwise specified.

For a better understanding of the invention, reference is made to the following detailed description, which should be read in conjunction with the accompanying drawings.

1 is a schematic diagram of one embodiment of an electrical stimulation system including a lead electrically coupled to a control module. FIG. 2 is a schematic diagram of one embodiment of the control module of FIG. 1 constructed and arranged to electrically couple to an elongated device; FIG. 2B is a schematic diagram of one embodiment of a lead extension constructed and arranged to electrically couple the elongated device of FIG. 2A to the control module of FIG. 1; FIG. FIG. 3 is a schematic perspective view of an embodiment of a cuff with two sets of 16 longitudinal electrodes and two radial electrodes each. FIG. 3 is a schematic perspective view of another embodiment of a cuff, each having four sets of 16 longitudinal electrodes and three radial electrodes. FIG. 3 is a schematic perspective view of one embodiment of a cuff with four sets of 16 longitudinal electrodes each and three sets of two radial electrodes each. FIG. 3 is a schematic perspective view of one embodiment of a cuff each having four sets of 32 longitudinal electrodes and two radial electrodes. This is a photograph of a cross section of a portion of the vagus nerve. 7 is a cross-sectional view of the cuff of FIG. 6 placed around a portion of the vagus nerve; FIG. 1 is a schematic illustration of one embodiment of the components of an electrical stimulation arrangement according to an embodiment of the invention; FIG.

The present invention relates to the field of implantable electrical stimulation systems and methods of making and using the systems. The present invention also relates to implantable electrical stimulation cuff devices and methods of making and using the same.

A suitable implantable electrical stimulation system includes, but is not limited to, at least one lead having one or more electrodes disposed along the distal end of the lead. Leads include, for example, percutaneous leads, paddle leads, and cuff leads. Examples of electrical stimulation systems having leads include, for example, U.S. Pat. Specification No. 6,741,892, Specification No. 7,203,548, Specification No. 7,244,150, Specification No. 7,450,997, Specification No. 7,596,414 Specification No. 7,610,103, Specification No. 7,672,734, Specification No. 7,761,165, Specification No. 7,783,359, Specification No. 7,792,590 Specification No. 7,809,446, Specification No. 7,949,395, Specification No. 7,974,706, Specification No. 6,175,710, Specification No. 6,224,450 No. 6,271,094, No. 6,295,944, No. 6,364,278, and No. 6,391,985, U.S. Patent Application Publication No. 2007/0150036 specification, 2009/0187222 specification, 2009/0276021 specification, 2010/0076535 specification, 2010/0268298 specification, 2011/0004267 specification, 2011/ Specification No. 0078900, Specification No. 2011/0130817, Specification No. 2011/0130818, Specification No. 2011/0238129, Specification No. 2011/0313500, Specification No. 2012/0016378, Specification No. 2012/0046710 Specification, Specification No. 2012/0071949, Specification No. 2012/0165911, Specification No. 2012/0197375, Specification No. 2012/0203316, Specification No. 2012/0203320, Specification No. 2012/0203321 , 2012/0316615, and 2013/0105071, and U.S. Patent Application Nos. 12/177,823 and 13/750,725, all of which They are incorporated by reference in their entirety.

FIG. 1 schematically depicts one embodiment of an electrical stimulation system 100. The electrical stimulation system includes a control module (eg, a stimulator or pulse generator) 102 and a lead 103 connectable to the control module 102. Lead 103 includes a mount 162 and a cuff 150. Lead 103 includes one or more lead bodies 106, an array 133 of electrodes, such as electrode 134, and an array of terminals (e.g., 210) in FIGS. 2A-2B. In at least some embodiments, the lead is of equal diameter along at least a portion of the longitudinal length of the lead body 106. FIG. 1 illustrates one lead 103 coupled to control module 102. Other embodiments may include two, three, four, or more leads 103 coupled to control module 102. In yet other embodiments, lead 103 may be coupled to multiple control modules 102. For example, a lead with 64 electrodes may be coupled to two control modules 102, each capable of handling 32 electrodes.

Lead 103 may be coupled to control module 102 in any suitable manner. In at least some embodiments, lead 103 couples directly to control module 102. In at least some other embodiments, lead 103 couples to control module 102 through one or more intermediate devices (200 in FIGS. 2A-2B). For example, in at least some embodiments, one or more lead extensions 224 (see, e.g., FIG. 2B) may extend the distance between the lead 103 and the control module 102 to extend the distance between the lead 103 and the control module 102. can be placed between. Other intermediate devices, including, for example, splitters or adapters, or combinations thereof, may be used in addition to or in place of one or more lead extensions. It will be appreciated that when electrical stimulation system 100 includes a plurality of elongated devices disposed between lead 103 and control module 102, the intermediate devices may be configured in any suitable arrangement. .

In FIG. 1, an electrical stimulation system 100 is shown having a splitter 107 constructed and arranged to facilitate coupling of a lead 103 to a control module 102. Splitter 107 is configured and arranged to couple to control module 102 (or another splitter, lead extension, adapter, etc.) with splitter connector 108 configured to couple to the proximal end of lead 103. one or more proximal tail portions 109a and 109b. Splitter 107 and splitter connector 108 may be part of lead 103 or may be separate components attached to the lead.

Control module 102 typically includes a connector housing 112 and a sealed electronics housing 114. Stimulation circuit 110 and optional power supply 120 are located in electronics housing 114. Control module connector 144 is located in connector housing 112. Control module connector 144 is constructed and arranged to provide an electrical connection between lead 103 and stimulation circuit 110 of control module 102 .

The electrical stimulation system or components, including lead body 106 and control module 102, are typically implanted within a patient's body. Electrical stimulation systems can be used for a variety of applications including, but not limited to, brain stimulation, nerve stimulation, spinal cord stimulation, muscle stimulation, and the like.

Lead body 106 can be made of, for example, non-conductive, biocompatible materials such as silicone, polyurethane, polyetheretherketone (“PEEK”), and epoxy, or combinations thereof. Lead body 106 may be formed into the desired shape by any process including, for example, molding (including injection molding), casting, and the like. The non-conductive material typically extends from the distal end of lead body 106 to the proximal end of lead body 106.

Terminals (e.g., 210 in FIGS. 2A-2B) typically connect electrical stimulation system 100 (as well as any splitters, (such as a lead extension, or adapter) along the proximal end of the lead body 106. Connector contacts are placed on a connector (e.g., 144 in FIGS. 1-2B and 222 in FIG. 2B), which in turn is placed on, for example, control module 102 (or lead extension, splitter, adapter, etc.). Ru. Conductive wires 160 or cables or the like (only one of which is shown in FIG. 1) extend from the terminals to the electrodes 134. Typically, one or more electrodes 134 are electrically coupled to each terminal. In at least some embodiments, each terminal is connected to only one electrode 134.

Conductive wires (“conductors”) 160 (only one shown in FIG. 1 for clarity) may be embedded in the non-conductive material of the lead body 106 or extend along the lead body 106. It can be placed in one or more lumens (not shown). In some embodiments, there is an individual lumen for each conductor. In other embodiments, two or more conductors extend through the lumen. Also, one or more lumens (see FIG. (not shown) may exist. In addition, one or more lumens (not shown) may open at or near the distal end of lead body 106 for, for example, injection of a drug or agent into the site of implantation of lead body 106. ) may exist. In at least one embodiment, the one or more lumens are flushed continuously or periodically, such as with saline or epidural fluid. In at least some embodiments, one or more lumens are permanently or removably sealable at the distal end.

FIG. 1 also illustrates a mount 162 that is part of the lead body 106 coupled to the cuff 150. Conductors 160 (only one of which is shown in FIG. 1 for clarity) from within lead body 106 are received in mount 162, which in turn connects each conductor to one of electrodes 134. Attached to cuff 150 is passed through mount 162 for direct electrical connection with one (eg, one conductor electrically connects with one electrode, etc.). Mount 162 may be attached using a variety of means, including, but not limited to, molding or gluing mount 162 to cuff 150. In other embodiments, the conductor 160 from within the lead body 106 is electrically coupled to the electrode 134 using a jumper, intermediate wire, or transition wire from the lead body 106 to the electrode 134.

Mount 162 may be offset from cuff 150, as shown in FIG. 1, in line with the cuff, or any other suitable arrangement. Examples of CuffLead 103 are disclosed in U.S. Patent Nos. 7,596,414; 7,974,706; , 493,269, 10,709,888, and 10,814,127, and U.S. Patent Application Publication No. 2017/0333692 and 2018/0154156. all of which are incorporated herein by reference in their entirety.

FIG. 2A is a schematic side view of one embodiment of a proximal end of one or more elongate devices 200 constructed and arranged to couple to one embodiment of control module connector 144. The one or more elongated devices may include, for example, the lead body 106, one or more intermediate devices (e.g., lead extension 224 of FIG. 2B, or an adapter, or a combination thereof), or a combination thereof. . FIG. 2A illustrates two elongated devices 200 coupled to control module 102. These two elongated devices 200 can be two tails as shown in FIG. 1, or two different leads, or any other combination of elongated devices.

Control module connector 144 defines at least one port into which the proximal end of elongate device 200 can be inserted, as indicated by directional arrow 212. In FIG. 2A (and in other figures) connector housing 112 is shown having two ports 204a and 204b. Connector housing 112 may define any suitable number of ports, including, for example, 1, 2, 3, 4, 5, 6, 7, 8, or more ports.

Control module connector 144 also includes a plurality of connector contacts, such as connector contacts 214 located within each port 204a and 204b. When elongate device 200 is inserted into ports 204a and 204b, connector contacts 214 are aligned with a plurality of terminals 210 disposed along the proximal end of elongate device 200 to connect control module 102 to lead 103. It can be electrically coupled to an electrode (134 in FIG. 1) located at the distal end. Examples of connectors within control modules are found, for example, in US Pat. Nos. 7,244,150 and 8,224,450, which are incorporated by reference in their entirety.

FIG. 2B is a schematic side view of another embodiment of electrical stimulation system 100. Electrical stimulation system 100 includes a lead extension 224 that couples one or more elongate devices 200 (e.g., lead body 106, an adapter, or another lead extension, or a combination thereof) to control module 102. constructed and arranged to do so. In FIG. 2B, lead extension 224 is shown coupled to a single port 204 defined within control module connector 144. Additionally, a lead extension 224 is shown constructed and arranged to couple to a single elongate device 200. In an alternative embodiment, the lead extension 224 is configured and configured to couple to a plurality of ports 204 defined within the control module connector 144 and/or to receive a plurality of elongated devices 200. Placed.

Lead extension 224 is disposed on lead extension connector 222. In FIG. 2B, lead extension connector 222 is shown located at distal end 226 of lead extension 224. In FIG. Lead extension connector 222 includes a connector housing 228. Connector housing 228 defines at least one port 230 into which terminal 210 of elongated device 200 can be inserted, as indicated by directional arrow 238. Connector housing 228 also includes a plurality of connector contacts, such as connector contacts 240. When elongate device 200 is inserted into port 230, connector contacts 240 located on connector housing 228 are aligned with terminals 210 of elongate device 200 and lead extensions 224 are aligned with leads (103 in FIG. 1). It can be electrically coupled to a disposed electrode (134 in FIG. 1).

In at least some embodiments, the proximal end of lead extension 224 is constructed and arranged similarly to the proximal end of lead 103 (or other elongated device 200). Lead extension 224 may include a plurality of conductive wires (not shown) that electrically couple connector contacts 240 to a proximal end 248 of lead extension 224 opposite distal end 226. In at least some embodiments, a conductive wire disposed on lead extension 224 is electrically coupled to a plurality of terminals (not shown) disposed along proximal end 248 of lead extension 224. Can be done. In at least some embodiments, the proximal end 248 of the lead extension 224 is configured and arranged for insertion into a connector located on another lead extension (or another intermediate device). In other embodiments (and as shown in FIG. 2B), the proximal end 248 of the lead extension 224 is configured and arranged for insertion into the control module connector 144.

Conventional cuff leads include a cuff that is wrapped around a portion of a nerve with one or more electrodes disposed on the cuff. In many conventional cuff leads, the individual electrodes also wrap around at least a portion of the circumference of the nerve in a radial wrapping arrangement. A radial wrapping arrangement of electrodes typically results in stimulation of the peripheral area of the nerve.

However, nerves are not monolithic biological constructs; rather, nerves are instead made of many fibers (which can be arranged in groups) that extend longitudinally along the nerve. FIG. 7 is a cross-section of a portion of the vagus nerve 280 illustrating the many fibers 282 within the nerve. In some cases, it may be desirable to stimulate only one fiber or group of fibers.

Electrodes in a radial wrap arrangement are generally not able to selectively stimulate fibers or groups of fibers; rather, such electrodes extend around the outer circumference of the nerve, resulting in Stimulates many fibers. In addition to this, such electrodes may produce undesirable side effects as multiple nerve fibers are stimulated. For example, a cuff lead where the cuff is around the vagus nerve can have a wide range of effects when stimulating the vagus nerve, since different fibers connect to many parts of the body.

As further described herein, the cuff lead can include a cuff body that wraps around the circumference of the nerve and includes longitudinal electrodes distributed about the circumference of the cuff body. In at least some embodiments, these longitudinal electrodes allow targeting selected longitudinal regions along the circumference of the cuff body. In at least some embodiments, these include at least 16, 20, 25, 28, 32, 36, 40, 48, 50, 64, 80, 100, 120, arranged in sets around the circumference of the cuff body. 128, 150, 200, 250, 256, or more longitudinal electrodes, and there are 1, 2, 3, or more sets of longitudinal electrodes spaced longitudinally from each other along the cuff body. There are cases where

In at least some embodiments, the cuff may also include one or more radial electrodes that can be used as a counter electrode to the one or more selected longitudinal electrodes. In at least some embodiments, one or more of the longitudinal electrodes can be used as a cathode and one or more of the radial electrodes can be used as an anode. Any other suitable selection of cathode or anode from longitudinal or radial electrodes can be used.

In at least some embodiments, a longitudinal electrode can be used to selectively stimulate a nerve fiber or set of nerve fibers. For example, a cuff lead around the vagus nerve selectively stimulates immunomodulatory fibers without stimulating (or reducing or below threshold stimulation of) cardiovascular or corporal fibers within the nerve. It may be used for. For example, immunomodulatory fibers may be used to enhance, reduce, or stop signals to or from the brain. In at least some embodiments, a cuff lead with a longitudinal electrode can be used to selectively provide fiber or fascial stimulation.

FIG. 3 illustrates one embodiment of a cuff 350 of cuff lead 103 (FIG. 1). Cuff 350 includes a cuff body 352 having longitudinal electrodes 334 disposed on an inner surface 354 of the cuff body and arranged around the circumference of the cuff body in two sets 356a, 356b. In the illustrated embodiment, each set 356a, 356b includes 16 longitudinal electrodes 334. but not limited to, 16, 20, 25, 28, 32, 36, 40, 48, 50, 64, 80, 100, 120, 128, 150, 200, 250, 256, or more Any other suitable number of electrodes can be used, including multiple longitudinal electrodes. The cuff lead can have one, two, three, four, or more sets of longitudinal electrodes 334. The number of longitudinal electrodes 334 within a set can be the same or different for each set. In the illustrated embodiment, each set of longitudinal electrodes 334 is longitudinally aligned with the other set of electrodes. In other embodiments, each set of longitudinal electrodes 334 may be interleaved or unaligned with the other set of electrodes.

In addition, the cuff 350 includes two radial electrodes 358a, 358b that wrap around at least 75%, 80%, 90%, or 95% of the circumference of the cuff body 352. The cuff 350 also defines a slit 360 extending the longitudinal length of the cuff body 352 so that the nerve can be loaded into the interior 362 of the cuff body by opening the slit and fitting the cuff body over the nerve. can. Slit 360 allows a target nerve (not shown) to be slid, inserted, delivered, or otherwise received into cuff 350 such that cuff 350 wraps around the target nerve. is opened or initially sized to allow. In at least some embodiments, the slit 360 allows the cuff 350 to be easily moved over and around or relative to the target nerve, whether rotationally or transitionally.

Electrodes 334, 358a, 358b can be formed using any electrically conductive, biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, conductive carbon, and the like, and combinations thereof. In at least some embodiments, one or more of the electrodes 334 are platinum, platinum alloys such as platinum iridium, palladium alloys such as palladium rhodium, titanium, titanium alloys, nickel alloys, cobalt alloys, nickel/ Formed from one or more of the following: cobalt alloy, stainless steel, tantalum, conductive carbon, conductive plastic, epoxy or other adhesive filled with metal powder, or Nitinol®, etc., or any combination thereof. be done. The electrodes 334, 358a, 358b may be formed by any method including, but not limited to, machining, forming (e.g., powder metal forming), photolithography, additive techniques, or stamping, or any combination thereof. It can be formed by a suitable process.

In at least some embodiments, the electrodes 334, 358a, 358b have contact surfaces that are flush with or slightly protrude from the cuff body 352 (e.g., no more than 200, 100, or 50 μm). , which may reduce or eliminate physical pressure on the nerve, at least in some situations. It will be appreciated that the electrodes can be used to provide electrical stimulation or to sense electrical signals from tissue, or any combination thereof.

In at least some embodiments, the elongated electrode 334 has a width of no greater than 100, 75, 50, 40, 30, or 25 micrometers (μm) and a width of at least 1, 2, 3, 4, 5, 7, or a larger length in millimeters (mm). The width of the longitudinal electrode corresponds to the circumferential distance 351 around the cuff body. In at least some embodiments, the length of longitudinal electrode 334 is no greater than 10 mm. The length of the longitudinal electrode corresponds to the distance along the longitudinal direction 353 of the cuff body. In at least some embodiments, the elongated electrode 334 has an aspect ratio (length/width) of at least 20, 40, 50, 80, 100, 150, 200, or greater. In at least some embodiments, each of electrodes 334 has the same width, length, and aspect ratio. In other embodiments, the electrodes 334 can have different widths, lengths, or aspect ratios, and the electrodes of a set have the same or different widths, lengths, or aspect ratios within or between the sets. have

In at least some embodiments, the elongated electrode 334 is rectangular or rectangular with rounded corners. Any shape including, but not limited to, an oval, an ellipse, a modified rectangle with one or more curved sides (or portions of sides), or any combination thereof. Other suitable shapes can be used for the elongated electrodes. The length and width measurements described in the immediately preceding paragraph correspond to the longest or widest portion of electrode 334. For example, for an elliptical electrode, the length along the major axis of the ellipse corresponds to the length measurement, and the length along the minor axis corresponds to the width measurement.

The narrow width of the longitudinal electrode 334 can facilitate the ability to select a particular fiber or group of fibers within the nerve and steer stimulation to the selected fiber or group of fibers. The number of longitudinal electrodes 334 in each set can further increase fiber selectivity by providing more selectivity with increasing number of longitudinal electrodes 334. Stimulation can be performed using one or more of the longitudinal electrodes 334. Selection of a suitable radial electrode 358a, 358b (or one or more of longitudinal electrodes 334) as a counter electrode can further enhance steering of stimulation to a selected fiber or group of fibers.

Cuff body 352 may be made of any suitable material, including, but not limited to, polymeric materials such as silicone, polyurethane, polyetheretherketone ("PEEK"), or epoxy, or any combination thereof. It can be made of a biocompatible, biostable, non-conductive material. In at least some embodiments, the cuff body 352 can have a circular, oval, or any other suitable cross-sectional shape, and in at least some embodiments, the cuff body 352 can have a cross-sectional shape to receive a nerve. It may be flexible enough to change. In at least some embodiments, the electrodes 334, 358a, 358b can be molded with the cuff body 352 or formed by techniques such as etching or ablation of a conductive layer or film. In at least some embodiments, the cuff body 352 has an inner diameter in the range of 0.5 to 5 mm or in the range of 1 to 3 mm (which can correspond to the maximum diameter of a non-circular cuff body). In at least some embodiments, cuff body 352 has a length of at least 5, 10, or 20 mm.

In at least some embodiments, the cuff body 352 is formed using any suitable technique including, but not limited to, molding, casting, and is formed into a sheet followed by a binder. shaped using adhesive, formed flat and shaped using heat, formed flat and attached to a cuffed scaffold, or pressed or extruded into a cuffed shape, etc. It can be formed by a combination of In at least some embodiments, the electrode 334 can be attached by, but not limited to, adhesively attached, molded to the cuff body (e.g., insert molded), or using heat to bond the electrode to the cuff body. , heating the electrode and forcing it into the cuff body, or depositing electrode material onto the cuff body using photolithography and etching, or any combination thereof. It can be attached to the cuff body 352 using.

In at least some embodiments, the inner surface 354 of the cuff body 352 can be coated with a cushioning layer 364 (FIG. 8) that acts as a cushion to reduce damage to the nerve. Examples of materials for the buffer layer 364 include, but are not limited to, paraffin and/or a combination of isotonic saline and artificial cerebrospinal fluid. Buffer layer 364 is made of a material that allows current flow from electrode 334 through the buffer layer to the nerve.

In at least some embodiments, with the cuff 350 in the desired position relative to the target nerve, the edge of the cuff body 352 defining the slit 360 is configured to capture the target nerve without unnecessarily compressing the target nerve. can be sutured. In at least some embodiments, suture holes (not shown) are optionally incorporated into the edge of cuff 350 to allow closing or partially closing cuff 350 around the target nerve. .

FIG. 4 illustrates another embodiment of a cuff 350 having a cuff body 352 and longitudinal electrodes 334 arranged in four groups 356a, 356b, 356c, 356d with 16 electrodes in each group. Cuff 350 includes three radial electrodes 358a, 358b, 358c.

FIG. 5 illustrates another embodiment of a cuff 350 having a cuff body 352 and longitudinal electrodes 334 arranged in four groups 356a, 356b, 356c, 356d with 16 electrodes in each group. Cuff 350 includes six radial electrodes each extending around less than half the circumference of cuff body 352 (e.g., at least 25%, 30%, 33%, 40%, 45%, or 48% of the circumference of the cuff body). 358a, 358b, 358c, 358d, 358e, 358f, two of these radial electrodes are arranged in each of three sets. It will be appreciated that other arrangements may include, for example, three, four, six, or more radial electrodes (or any other number of radial electrodes) per set. The radial electrodes of the set can extend the same amount around the circumference of the cuff body 352 or can extend different amounts around the circumference of the cuff body. Each set can be identical, or the sets can have different arrangements of radial electrodes. In at least some embodiments, the radial electrodes of the set extend in combination around at least 75%, 80%, 90%, or 95% of the circumference of the cuff body 352.

FIG. 6 illustrates yet another embodiment of a cuff 350 having a cuff body 352 and longitudinal electrodes 334 arranged in four groups 356a, 356b, 356c, 356d with 32 electrodes in each group. There is. Cuff 350 includes two radial electrodes 358a, 358b.

FIG. 8 illustrates a cross-section of the cuff 350 of FIG. 6 disposed about the vagus nerve 280, with longitudinal electrodes 334 arranged around the cuff and the circumference of the vagus nerve. Optionally, a buffer layer 364 is disposed between the cuff 350/electrode 334 and the nerve 280.

Cuff lead 103 (FIG. 1) may be coupled to one or more control modules 102 (FIG. 1). If the cuff lead 103 has many longitudinal electrodes 334, multiple control modules 102 can be used to independently control the longitudinal electrodes 334. Additionally or alternatively, multiplexing techniques and arrangements may be used to provide stimulation to selected longitudinal electrodes 334. The multiplexing arrangement may be part of the control module 102, the cuff lead 103, or separate modules, or any combination thereof. Examples of multiplexing and independent control and delivery of stimulation through selected electrodes can be found in U.S. Pat. No. 9,308,383, No. 9,568,053, No. 10,350,413, and No. 10,537,741, and U.S. Patent Application Publications No. 2018/0071520 and No. 2019/0083796, all of which are incorporated herein by reference in their entirety.

FIG. 9 is a schematic diagram of one embodiment of the components of an electrical stimulation arrangement 904 that includes an electrical stimulation system 900 having a lead 902, a stimulation circuit 906, a power source 908, and an antenna 910. The electrical stimulation system can be, for example, any of the electrical stimulation systems described above. It is understood that electrical stimulation arrangements can include more, fewer, or different components and can have a variety of different configurations, including those disclosed in the stimulator references listed herein. will be done.

If power source 908 is a rechargeable battery or a rechargeable capacitor, the power source may be recharged/charged using antenna 910 if desired. Power for recharging/charging may be provided by inductively coupling power source 908 through antenna 910 to a recharging unit 936 external to the user. Examples of such arrangements can be found in the documents identified above.

In at least some embodiments, electrical current is emitted by an electrode (such as electrode 134 in FIG. 1) on lead 902 to stimulate nerve fibers, muscle fibers, or other body tissue near the electrical stimulation system. be done. Stimulation circuit 906 can include a processor 934 and a receiver 932, among other components. A processor 934 is typically included to control the timing and electrical characteristics of the electrical stimulation system. For example, processor 934 can control one or more of the timing, frequency, intensity, duration, and waveform of the pulses, if desired. Additionally, processor 934 can select which electrodes can be used to provide stimulation, if desired. In some embodiments, processor 934 selects which electrode is the cathode and which electrode is the anode. In some embodiments, processor 934 is used to identify which electrodes provide the most useful stimulation of the desired tissue.

Any processor can be used and can be as simple as, for example, an electronic device that generates pulses at regular intervals, or the processor can be an external programming unit that allows for example modification of the pulse characteristics. 938 and may have the ability to receive and interpret instructions from the 938. In the illustrated embodiment, processor 934 is coupled to receiver 932, which in turn is coupled to antenna 910. This allows processor 934 to receive instructions from an external source that dictate pulse characteristics and electrode selection, for example, if desired.

In at least some embodiments, antenna 910 is capable of receiving signals (eg, RF signals) from external telemetry unit 940 that are programmed by programming unit 938 . Programming unit 938 may be external to or part of telemetry unit 940. Telemetry unit 940 can be a device that can be worn on the user's skin or carried by the user and, if desired, takes the form of a pager, cell phone, or remote control. can have As another alternative, telemetry unit 940 may not be worn or carried by the user, but rather may only be available at a home station or clinician's office. Programming unit 938 can be any unit that can provide information to telemetry unit 940 for transmission to electrical stimulation system 900. Programming unit 938 may be part of telemetry unit 940 or may provide signals or information to telemetry unit 940 through a wireless or wired connection. An example of a suitable programming unit is a computer operated by a user or clinician to send signals to telemetry unit 940.

Signals sent through antenna 910 and receiver 932 to processor 934 can be used to modify or otherwise direct the operation of electrical stimulation system 900. For example, the signal may be used to modify the pulses of the electrical stimulation system, such as modifying one or more of pulse duration, pulse frequency, pulse shape, and pulse intensity. The signal may also instruct the electrical stimulation system 900 to stop operating, start operating, start charging the battery, or stop charging the battery.

Optionally, electrical stimulation system 900 includes a transmitter (not shown) coupled to processor 934 and antenna 910 for transmitting signals back to telemetry unit 940 or another unit capable of receiving the signals. There are cases. For example, the electrical stimulation system 900 may transmit a signal indicating whether the electrical stimulation system 900 is operating properly or when the battery needs to be charged or the level of charge remaining on the battery. . Processor 934 may also have the ability to transmit information regarding pulse characteristics to a user or clinician so that the characteristics can be determined or verified.

The foregoing specification provides a description of the structure, manufacture, and use of the present invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims appended hereto.

334 Longitudinal electrode 352 Cuff body 354 Inner surface 358a, 358b of cuff body Radial electrode 360 Slit

Claims (15)

A cuff,
a cuff body having an outer surface, an inner surface, and a periphery;
a plurality of longitudinal electrodes disposed on the inner surface of the cuff body, each of the longitudinal electrodes having a length/width aspect ratio of at least 20; the plurality of longitudinal electrodes being divided into at least one set, each set comprising at least 16 of the longitudinal electrodes spaced apart from each other in a circumferential arrangement around the periphery of the cuff; and extending through the cuff body. further comprising: a longitudinal slit extending along the entire length of the cuff body, the longitudinal slit being operable to receive a portion of the target nerve from an area outside the cuff into the cuff body;
the cuff including;
a lead body coupled to the cuff;
a plurality of conductors extending through the lead body and the cuff and electrically coupled to the longitudinal electrode;
An electrical stimulation lead characterized by comprising: The electrical stimulation lead of claim 1, wherein each of the longitudinal electrodes has a width of no greater than 100 μm. 3. The electrical stimulation lead of claim 1 or 2, wherein the cuff further comprises at least one radial electrode extending around at least 75% of the circumference of the cuff body. The cuff further comprises at least one set of radial electrodes;
4. Each set of radial electrodes comprises at least two of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body. Electrical stimulation leads as described. A cuff,
a cuff body having an outer surface, an inner surface, and a periphery;
a plurality of longitudinal electrodes disposed on the inner surface of the cuff body, each of the longitudinal electrodes having a width of no greater than 100 μm; said plurality of longitudinal electrodes being divided into at least one set, each set comprising at least 16 of said longitudinal electrodes spaced apart from each other in a circumferential arrangement about said cuff body; a longitudinal slit extending along the entire length of the body and operable to receive a portion of the target nerve from an area outside the cuff into the cuff body;
The cuff comprising;
a lead body coupled to the cuff;
a plurality of conductors extending through the lead body and the cuff and electrically coupled to the longitudinal electrode;
An electrical stimulation lead characterized by comprising: 6. The electrical stimulation lead of claim 5, wherein the cuff further comprises at least one radial electrode extending around at least 75% of the circumference of the cuff body. The cuff further comprises at least one set of radial electrodes;
7. The electrical stimulation lead of claim 5 or 6, wherein each set of radial electrodes comprises at least two of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body. . A cuff,
a cuff body having an outer surface, an inner surface, and a periphery;
a plurality of longitudinal electrodes disposed on the inner surface of the cuff body, the plurality of electrodes comprising at least 32 of the longitudinal electrodes spaced apart from each other in a circumferential arrangement around the periphery of the cuff body; the plurality of longitudinal electrodes divided into at least one set with each set comprising a plurality of longitudinal electrodes;
one or more radial electrodes extending around at least 75% of the circumference of the cuff body, alone or in combination of two or more of the radial electrodes; and a longitudinal slit extending through the cuff body and further along the length of the cuff body, the longitudinal slit being operable to receive a portion of the target nerve from an area outside the cuff into the cuff body. the longitudinal slit;
a cuff comprising;
a lead body coupled to the cuff;
a plurality of conductors extending through the lead body and the cuff and electrically coupled to the longitudinal and radial electrodes;
An electrical stimulation lead characterized by comprising: 9. The electrical stimulation lead of claim 8, wherein each of the longitudinal electrodes has a width of no greater than 100 μm. the cuff further comprising at least two sets of the radial electrodes;
10. The electrical stimulation lead of claim 8 or 9, wherein each set of radial electrodes comprises at least one of the radial electrodes extending around at least 75% of the circumference of the cuff body. 11. The electrical stimulation lead of claim 10, wherein at least one of the sets of radial electrodes comprises at least two of the radial electrodes extending in combination around at least 75% of the circumference of the cuff body. . An electrical stimulation lead according to any preceding claim, wherein the aspect ratio of each of the longitudinal electrodes is at least 50. An electrical stimulation lead according to any preceding claim, further comprising a buffer layer disposed over the inner surface of the cuff body. An electrical stimulation lead according to any preceding claim, wherein each of the longitudinal electrodes has a length of at least 1 mm. 15. Each of the at least one set comprises at least 32 of the longitudinal electrodes spaced apart from each other in a circumferential arrangement around the periphery of the cuff body. electrical stimulation leads.

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